BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 3092381 · Received May 3, 2013

    Report

    Report Number
    3004209178-2013-07273
    Event Type
    Malfunction
    Date Received
    May 3, 2013
    Report Date
    April 16, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3777-45, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011. PRODUCT TYPE: LEAD: PRODUCT ID 3777-45, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011. PRODUCT TYPE: LEAD: PRODUCT ID 37743, SERIAL# (B)(4). PRODUCT TYPE: PROGRAMMER, PATIENT: PRODUCT ID 37752, SERIAL# (B)(4). PRODUCT TYPE: RECHARGER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD WOKEN UP TO A POWER ON RESET (POR) MESSAGE DISPLAYED. IT WAS NOTED THAT THE SYSTEM WAS HALF CHARGED. IT WAS FURTHER NOTED THAT THE POR WAS RESET AND THAT THE DEVICE HAD RESTARTED "WITHOUT PROBLEM." ADDITIONAL INFORMATION REPORTED THAT THE DIAGNOSTIC CODE THAT ACCOMPANIED THE POR WAS NOT KNOWN. THE CAUSE OF THE POR WAS NOT DETERMINED. IT WAS NOTED THAT NO PATIENT SYMPTOMS WERE EXPERIENCED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    194678 RESTORE ULTRA STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37712

    Patients

    Seq Age Sex Outcome Treatment
    1